Four Indian vaccine makers have license suspended after failing GMP
licenses suspended by the Indian government after failing to meet
good manufacturing practise (GMP) requirements, according to local
media reports.
The firms involved are the Pasteur Institute of India in Tamil Nadu, Haffkine Bio-Pharmaceutical Corporation in Mumbai, BCG Vaccines in Tamil Nadu and Central Research Institute (CRI) in Himachal Pradesh, according to India's Economic Times. Reportedly, the Central Drugs Licensing Approving Authority, headed by the Drug Controller General of India (DCGI), has immediately halted production at the sites, which make vaccines for a range of diseases such as malaria, cholera, rabies, polio, diphtheria, tetanus, yellow fever and typhoid. Their licences have been revoked until the companies make changes to their infrastructure and processes and begin to fully comply with GMP standards. This might take "six months or a year", a government source told the Economic Times. Outsourcing-pharma.com has made attempts to contact each of the companies involved to obtain comment on the situation although none have been reachable. However, according to Express India, Dr K.R. Mani, director of the government-funded CRI, confirmed the suspension at his organisation and said he has taken up the issue with the Union Health Ministry and hopes that production would start soon after getting fresh orders. Pardeep Nathani, the general secretary of CRI Employees' Association also confirme the decision, calling it "unjustified" and said if it was not revoked, the union would file a petition in the court. "The suspension of the licence without giving adequate warning to the institute has left over 600 workers unemployed", he said. According to an Express India source, the CRI was found to be in "serious violation" of GMP norms after an inspection by a team of experts and drug officials was conducted in August, 2007. At the time, the institute reportedly sought a grace period of two years to remedy the situation and requested between 35 crore ($7m) and 55 crore for the purpose, but despite this, the team visited the CRI again in the first week of January this year and upon finding that the violations still persisted, served the organisation with the suspension order shortly after. The proactive move may be part of a crackdown by the Indian government, keen to claw back its international reputation after the country was identified by the World Health Organization (WHO) for having manufacturing standards that fall short of GMP, particularly in the field of vaccines. According to the Economic Times, it was the WHO that recommended the suspension of the four firms' licences and was even considering removing India from its list of countries to source vaccines for its global projects. This would have been a severe blow to the industry, as most of the vaccine makers, including those in the private sector, have large contracts with WHO. However, according to India's Organiser, some smell a conspiracy, citing the CRI as an example, which is famous for its work in the research, testing and manufacturing of vaccines for countries around the world. The CRI manufactures vaccines and medicines and makes supply of worth 20 crore to the Indian government at a very cheap price and according to an Organiser source, this was "a cause of worry" to the multinational companies (MNCs) in the region, who were being prevented from "capturing the market of vaccines". In addition to a suspension of its manufacturing licence, company sources told the Organiser that the CRI has also had its supply of medicines to the government stopped until further notice, meaning that "in the present circumstances, the huge market of vaccines would be in the hands of MNCs".
